The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Cholerascreen.
| Device ID | K922432 |
| 510k Number | K922432 |
| Device Name: | CHOLERASCREEN |
| Classification | Antiserum, Vibrio Cholerae, All Varieties |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Contact | Marjorie I Wier |
| Correspondent | Marjorie I Wier NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Product Code | GSQ |
| CFR Regulation Number | 866.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1992-12-07 |